NCT01056367

Brief Summary

The risk of cardiovascular disease (CVD) in patients with type-II-diabetes mellitus (type-II-DM)is more than doubled and CVD accounts for 70% of deaths in this group of patients. Hypertension is a major risk factor for CVD in patients with type-II-DM and a major contributor cardiovascular mortality. Uncontrolled- (UH) and resistant hypertension (RH)are more common in patients with type-II-DM, why further bloodpressure (BP) control is needed. The prevalence of UH and RH has not been examined in a consecutive Danish outpatient population with type-II-DM. The purpose of this study is to examine the prevalence of resistant hypertension in patients with type-II-diabetes and to examine the characteristics of patients with resistant hypertension as compared to patients with controlled hypertension with regards to arterial stiffness.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 26, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

October 12, 2011

Status Verified

October 1, 2011

Enrollment Period

2.1 years

First QC Date

January 25, 2010

Last Update Submit

October 9, 2011

Conditions

Resistant HypertensionNIDDM

Keywords

Resistant hypertensionType-II-Diabetes MellitusArterial stiffnessVentricular function

Outcome Measures

Primary Outcomes (1)

  • Pulse wave velocity

    one year

Secondary Outcomes (2)

  • Myocardial contractility

    One year

  • Pulse wave analysis

    One year

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients from diabetic outpatient clinic

You may qualify if:

  • years, informed consent, hypertension, type-II-diabetes mellitus

You may not qualify if:

  • Non-compliance, s-creatinin above 200, AFli

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medical Research, Svendborg Hospital

Svendborg, 5700, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Only serum and plasma samples are used and saved for later analysis.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Trine K Sønder, Cand.med.

    Department of Medical Research, Svendborg Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

January 25, 2010

First Posted

January 26, 2010

Study Start

June 1, 2009

Primary Completion

July 1, 2011

Study Completion

October 1, 2011

Last Updated

October 12, 2011

Record last verified: 2011-10

Locations

DK(1)